Color detection system for detecting reservoir presence and content in device

ABSTRACT

A system for identifying a reservoir used with a fluid delivery device. The system includes a reservoir comprising a housing for holding fluid and a colored marking located on a surface of the housing. A fluid delivery device includes a compartment for receiving and operatively coupling with the reservoir. A light source shines light on the colored marking of the reservoir. A color sensor detects wavelengths reflected and/or refracted from the colored marking due to the light shined on the colored marking. A processor of the delivery device determines a color of the colored marking from the detected wavelengths and ascertains information related to the reservoir or the fluid in the reservoir corresponding to the determined color, wherein the processor operates the fluid delivery device according to the ascertained information, wherein the information may include a reservoir type and/or medication type.

FIELD OF THE INVENTION

Embodiments of the present invention relate to a system for detectingthe presence and content of a reservoir used in a fluid delivery deviceby detecting a colored marking located on the reservoir.

BACKGROUND OF THE INVENTION

Infusion devices and systems have become relatively prevalent in themedical field for use in delivering or dispensing prescribed medicationsuch as insulin to a patient. In one form, such devices comprise atransportable, pocket-size pump housing capable of receiving a reservoirof medication for administration to the patient through an associatedcatheter or infusion set.

Infusion devices have significant advantages over traditional medicationdelivery methods because of their precision, consistency, andversatility. Patients are able to set exact dosage amounts and generallybenefit from receiving medication from pumps during physical activity orother occasions that would otherwise not easily be suited for doing so.As a result, infusion pumps have effectively reduced the restrictionsthat a diabetic patient's medical needs place upon him allowing thepatient to live a more active and fulfilling lifestyle.

Generally, medication reservoirs have been used with the infusiondevices to deliver medication to the patient. Typically, the medicationreservoir is operatively inserted in, or attached to, the infusiondevice. A plunger is then actuated to force medication out of thereservoir, and deliver the medication via a tube to an insertion site onthe patient.

Prior to methods being developed for detecting the presence oridentifying the contents of a medication reservoir, a user manuallychecked if the reservoir was attached or inserted into a deliverydevice. The user was also responsible for ensuring that the medicationor dosage was the correct one to administer. These steps are criticalbecause a lack of the reservoir in the infusion device prevents thepatient from receiving vital medication. Moreover, administration of anincorrect medication or dosage can lead to patient injury or death.Generally, the user must know what type of medication is beingadministered because there are often different dosing requirements fordifferent concentrations of the same medication.

To overcome the drawbacks concerning what type of medication iscontained in the reservoir, information related to the medication wasprinted on the exterior of the reservoir. However, this method suffersbecause the user must still view the printing on the reservoir andunderstand the information presented.

Other systems for providing information about the reservoir to thedelivery device have been developed but also suffer from variousdisadvantages. For example, a delivery system includes mechanicalswitches that are manipulated by the reservoir when the reservoir isinserted into the device to provide information about the reservoir.However, such a device is disadvantageous because inclusion of themechanical switches undesirably increases the size of the deliverydevice. Moreover, the switches must be accessible to the reservoir, andthus, it is difficult to maintain a waterproof device housing to protectthe internal components of the delivery device from any fluids escapingfrom the reservoir or otherwise entering the device. The system is alsosusceptible to error when the reservoir's orientation in the device isnot in an ideal position with respect to the switches.

In yet another example, a medication delivery system includes a bar codereader mounted in the delivery device. The bar code reader is used inconjunction with a medication reservoir having a bar code on itssurface. The bar code provides information related to the medicationcontained in the reservoir, such as type, volume, dosage, etc.Accordingly, when the reservoir is inserted into the delivery device,the bar code reader in the device reads the bar code on the reservoir,and uses the information obtained from the bar code to operate thedevice, or provide the information to the user on a device display.

However, such a system suffers from several drawbacks. For example, barcode readers need to be a certain distance away from the bar code toproperly read the bar code. Consequently, devices accommodating bar codereaders are larger in size, which is undesirable to users. Moreover, thebar codes on the reservoir require precise positioning in the device tobe properly read by the bar code reader. Hence, device reliability andaccuracy are easily lowered if the reservoir is moved slightly away fromits ideal position in the device.

SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to a system fordetecting the presence and content of a reservoir operatively coupled toa delivery device by detecting a colored marking located on thereservoir.

Additional features and advantages of embodiments of the invention willbe set forth in the description which follows, and in part will beapparent from the description, or may be learned by practice ofembodiments of the invention. The objectives and other advantages ofembodiments of the invention will be realized and attained by thestructure particularly pointed out in the written description and claimshereof as well as the appended drawings.

To achieve these and other advantages and in accordance with the purposeof embodiments of the present invention, as embodied and broadlydescribed, the present invention is embodied in a reservoir for use witha fluid delivery device for delivering fluid into a body from thereservoir, the reservoir including a housing for holding fluid, and atleast one colored marking located on a surface of the housing forproviding information related to the reservoir or the fluid in thereservoir to the fluid delivery device. In particular, the housing isadapted to operatively couple with the delivery device, and a color ofthe at least one colored marking is adapted to be determined by thefluid delivery device to provide the information related to thereservoir or the reservoir fluid in the reservoir corresponding to thedetermined color.

In some embodiments, the information includes at least one of amedication type, a medication expiration date, an amount of medicationcontained in the reservoir, a maker of the medication, a medicationconcentration, a medication dosage, a reservoir size, and a reservoirmaterial. The information may be stored in a memory of the deliverydevice.

In one embodiment, the at least one colored marking may include aplurality of colored markings. In another embodiment, the color of theat least one colored marking may be adapted to change to indicateinformation related to the reservoir or the fluid in the reservoir.

In yet another embodiment, a fluid delivery device for delivering fluidinto a body of a patient from a reservoir containing the fluid andhaving at least one colored marking that encircles a housing of thereservoir includes a compartment for receiving the reservoir, and thefluid delivery device operatively couples with the housing of thereservoir to deliver the fluid into the body of the patient from thereservoir. The fluid delivery device also includes a light source forshining light on the at least one colored marking of the reservoir, acolor sensor for detecting wavelengths reflected and/or refracted fromthe at least one colored marking due to the light shined on the at leastone colored marking, and a processor operatively coupled to the colorsensor for determining the color of the at least one colored markingfrom the detected wavelengths and ascertaining information related tothe reservoir or the fluid in the reservoir corresponding to thedetermined color.

The processor may ascertain the information related to the reservoir orthe reservoir fluid in the reservoir by acquiring information stored ina memory of the fluid delivery device corresponding to the determinedcolor. The processor may also operate the delivery device according tothe ascertained information. The processor may communicate to otherprocessors in the device. Further, if the processor determines a lack ofany color or detect the color of reservoir housing, the processor maydetermine that no reservoir has been received into the fluid deliverydevice. Moreover, the processor may determine a position of thereservoir in the fluid delivery device based on the determined color. Inan additional embodiment, the fluid delivery device may include a secondcolor sensor for detecting wavelengths reflected and/or refracted fromthe at least one colored marking due to the light shined on the at leastone colored marking.

In another embodiment of the present invention, a fluid delivery systemfor delivering fluid into a body of a patient includes a reservoir and afluid delivery device. The reservoir includes a housing for holding thefluid and at least one colored marking located on a surface of thehousing for providing information related to the reservoir or the fluidin the reservoir. The fluid delivery device includes a compartment forreceiving the reservoir, and the fluid delivery device operativelycouples with the housing of the reservoir to deliver the fluid into thebody of the patient from the reservoir. The delivery device alsoincludes a light source for shining light on the at least one coloredmarking of the reservoir and a color sensor for detecting wavelengthsreflected and/or refracted from the at least one colored marking due tothe light shined on the at least one colored marking. The deliverydevice further includes a processor operatively coupled to the colorsensor for determining the color of the at least one colored markingfrom the detected wavelengths and ascertaining information related tothe reservoir or the reservoir fluid in the reservoir corresponding tothe determined color.

In a further embodiment of the present invention, a characteristicmonitor system for monitoring a characteristic of a user comprises aremote device, a sensor set supporting a sensor for producing a signalindicative of the characteristic of the user, at least one coloredmarking located on a surface of the sensor set for providing informationrelated to the sensor set or the characteristic of the user, and atransmitter coupled to the sensor set for processing signals from thesensor set and transmitting the processed signals to the remote device,wherein the remote device utilizes the received processed signals todetermine the characteristic of the user. The transmitter comprises alight source for shining light on the at least one colored marking ofthe sensor set, a color sensor for detecting wavelengths reflectedand/or refracted from the at least one colored marking due to the lightshined on the at least one colored marking, and a processor operativelycoupled to the color sensor for determining a color of the at least onecolored marking from the detected wavelengths and ascertaininginformation related to the sensor set or the monitored characteristiccorresponding to the determined color.

It is to be understood that both the foregoing general description andthe following detailed description of the present invention areexemplary and explanatory and are intended to provide furtherexplanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the invention and are incorporated in and constitute apart of this specification, illustrate embodiments of the invention andtogether with the description serve to explain the principles of theinvention. Features, elements, and aspects of the invention that arereferenced by the same numerals in different figures represent the same,equivalent, or similar features, elements, or aspects in accordance withone or more embodiments.

FIG. 1A illustrates an exemplary fluid reservoir in accordance with anembodiment of the present invention.

FIG. 1B illustrates an exemplary fluid reservoir in accordance with anembodiment of the present invention having colored bands which extendpartially around the reservoir.

FIG. 1C illustrates an exemplary fluid reservoir in accordance with anembodiment of the present invention having different colored bands.

FIG. 1D illustrates an exemplary fluid reservoir in accordance with anembodiment of the present invention having a band with different colors.

FIG. 2A illustrates a side plan, cut-away view of an exemplary fluiddelivery device in accordance with an embodiment of the invention.

FIGS. 2B and 2C illustrate alternative embodiments of an exemplary fluiddelivery device in accordance with an embodiment of the invention.

FIG. 3 illustrates a method of operation of a fluid delivery system inaccordance with embodiments of the present invention.

FIGS. 4A and 4B illustrate a characteristic sensor system having asubcutaneous sensor insertion set and a telemetered characteristicmonitor transmitter in accordance with an embodiment of the presentinvention.

FIGS. 5A and 5B illustrate perspective views of a subcutaneous sensorinsertion set having a colored marking in accordance with embodiments ofthe present invention.

FIGS. 6A and 6B illustrate perspective views of a telemeteredcharacteristic monitor transmitter having a window in accordance withembodiments of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments of the present invention relate to detecting the presenceand/or determining information about a reservoir operatively coupled toa fluid delivery device based on a colored marking located on thereservoir.

As shown in the drawings for purposes of illustration, embodiments ofthe invention include a fluid reservoir or reservoir that is used inconjunction with a fluid delivery device for delivering fluid containedin the reservoir to a patient. In particular embodiments, the fluidreservoir is used to deliver medication, such as insulin, into thepatient's body. In further embodiments, the fluid reservoir may be usedto deliver medical substances, such as vitamins, hormones, vaccines,antibiotics or other medications, or other liquid substances, such asdyes, tracers or the like. The fluid reservoir includes a coloredmarking on a surface of the reservoir. When sensed by the deliverydevice, the colored marking allows the delivery device to detect thereservoir's presence, as well as determine characteristics of thereservoir and the fluid contained in the reservoir. In alternativeembodiments, the color may be formed inside the reservoir material (as aseparate insert, different colored material formed during the molding, alabel between layers in a multi-layer wall of a reservoir) as an opaqueor translucent section. In other alternatives, the color may be adheredto the interior of the reservoir. In particular embodiments, thereservoir has a circular cross-section forming a generally cylindricalcontainer. However, in alternative embodiments, the cross-section of thereservoir is oval, square, rectangular, triangular, polygonal (which mayinclude sharp or rounded corners), or the like.

Embodiments of the present invention may be implemented in an externalinfusion device including a housing worn on the exterior of thepatient's body generally of the type described in U.S. Pat. Nos.4,562,751; 4,678,408; 4,685,903; 5,080,653; 5,097,122; 5,505,709;6,248,093; 6,362,591; 6,554,798; 6,555,986; and 6,752,787, which arespecifically incorporated by reference herein in their entirety. Thecolored marking may be located on the fluid reservoir or other medicalfluid container used in conjunction with the external infusion device.When the colored marking is sensed by the infusion device, it mayindicate information including, but not limited to, medication type(e.g. type of insulin), expiration date, amount of medication containedin the reservoir, maker of the medication, medication dosage, properinsertion of the reservoir, reservoir size, reservoir material (e.g.Topas®, glass, etc.) or the like.

In further embodiments, the infusion device may include separate durableand disposable housing portions that selectively engage and disengagefrom each other and may be of the type generally described in U.S.application Ser. No. 11/211,095 filed Aug. 23, 2005 and entitled“Infusion Device and Method with Disposable Portion,” U.S. applicationSer. No. 11/588,875 filed Oct. 27, 2006 and entitled “Systems andMethods Allowing for Reservoir Filling and Infusion Medium Delivery,”U.S. application Ser. No. 11/515,225 filed Sep. 1, 2006 and entitled“Infusion Medium Delivery Device and Method with Drive Device forDriving Plunger in Reservoir,” U.S. application Ser. No. 11/588,847filed Oct. 27, 2006 and entitled “Infusion Medium Delivery Device andMethod with Compressible or Curved Reservoir or Conduit,” U.S.application Ser. No. 11/646,000 filed Dec. 26, 2006 and entitled“Infusion Medium Delivery System, Device and Method with Needle Inserterand Needle Inserter Device and Method,” and U.S. application Ser. No.11/589,323 filed Oct. 27, 2006 and entitled “Infusion Pumps and Methodsand Delivery Devices and Methods with Same,” all of which areincorporated by reference herein in their entirety. The colored markingmay be located on the fluid reservoir used in conjunction with theinfusion device. When the colored marking is sensed by the durableportion of the infusion device, it may indicate information including,but not limited to, medication type (e.g. type of insulin), expirationdate, amount of medication contained in the reservoir, maker of themedication, medication dosage, proper insertion of the reservoir,reservoir size, reservoir material (e.g. Topas®, glass, etc.) or thelike. Alternatively, the colored marking may be located on thedisposable portion of the infusion device to indicate such informationas well as the usage life of the disposable portion. In furtheralternative embodiments, the colored marking may be located on thedurable portion of the infusion device, and may indicate informationsuch as the usage life of the durable portion.

Other embodiments of the present invention may be implemented in sensors(such as glucose, lactate, bacterial, viral, ph, oxygen, or the like),sensing systems, senor monitors and/or an infusion system that receivesdata from a sensor inserted into a patient's body as generally describedin U.S. patent application Ser. No. 10/867,529 entitled “System forProviding Blood Glucose Measurements to an Infusion Device” filed onOct. 14, 2004, or a characteristic monitoring system that receivescontinuous data from a sensor inserted into a patient's body asgenerally described in U.S. Pat. Nos. 6,248,067; 6,424,847; and6,895,263; and U.S. patent application Ser. No. 09/377,472, filed Aug.19, 1999 and entitled “Telemetered Characteristic Monitor System AndMethod Of Using The Same,” and U.S. patent application Ser. No.11/322,568, filed Dec. 30, 2005 and entitled “Telemetered CharacteristicMonitor System And Method Of Using The Same,” all of which areincorporated by reference herein in their entirety. Such systemstypically include a characteristic monitor coupled to a sensor setinserted into the patient's body to determine levels of a characteristicin the patient's body, such as blood glucose levels. The colored markingmay be located on the sensor set. When the colored marking is sensed bythe portion coupling the sensor set to the characteristic monitor (i.e.,cable connected between the sensor set and the monitor, transmitterconnected to the sensor set that wirelessly transmits data to themonitor), it may indicate information such as the usage life of thesensor (e.g., 3 days, 6 days), the analyte being sensed (e.g, glucose,lactate, bacterial, viral, ph, oxygen, or the like), calibration data,alarm thresholds, lot number, or the like.

An infusion device according to embodiments of the present invention mayinclude a housing to enclose a drive system, a fluid containmentassembly, and a power supply. The device's drive system generallyincludes a small motor (DC, stepper, solenoid, piezoelectric, pistondrive, peristaltic pump, shape memory alloy driven or other type) anddrive train components such as gears, screws and levers that act inconcert to convert rotational motor motion to translational displacementof a piston in a fluid reservoir. In some embodiments, the drive systemmay use gas, or other types of pressure systems that induce displacementof the piston in the fluid reservoir. The fluid containment assembly mayinclude the reservoir, flexible tubing, and a catheter or infusion setthat transports the fluid or medication from the infusion device to thebody of the user. Alternatively, the fluid containment assembly mayinclude the reservoir, and fluid or medication may be delivered directlyfrom the reservoir through the infusion device (without the necessity ofan infusion set and/or tubing) to the body of the user. The device'selectronic system may include programmable controls for regulating themotor, as well as for setting desired dosage intervals over a certainperiod of time.

FIG. 1A illustrates an exemplary medication reservoir in accordance witha particular embodiment of the present invention. Referring to FIG. 1A,a reservoir 10 includes a colored marking 12. The reservoir 10 is madeof a suitable glass or plastic material. However, in alternativeembodiments, the reservoir 10 may be made out of other materials, suchas composites, metals, ceramics, Topas® or the like. The marking 12 maybe a colored band encircling the reservoir 10, and may be placed on asurface of the reservoir 10 by means of a painted mark, printing,spraying, molding, adhered sticker, or the like. Alternatively, themarking 12 may be a single patch of color on one area of the reservoir,or a series of small patches extending around the circumference of thereservoir. The marking 12 may also be formed as part of a label thatincludes information such as text, trademarks, volume, identificationand lot number. This facilitates the marking 12 to be attached to thereservoir 10 in a single operation with the other information.

The colored marking 12 is not limited to colors in the visible spectrum.In particular embodiments, the marking 12 may be of an infrared and/orultraviolet color, the wavelengths of which are detectable by a colorsensor used in connection with embodiments of the present invention. Useof colors outside of the visible spectrum allows for greaterinformation-providing capabilities and/or prevents information frombeing visible to the user.

Alternatively, the marking 12 may be a colored band that extendspartially around the reservoir 10, as shown in FIG. 1B. When thereservoir 10 is inserted into a fluid delivery device, such as thedevice illustrated in FIG. 2, the device may actuate a plunger to forcemedication out of the reservoir 10 to be delivered to a patient via aninfusion set or the like that is adhered to the patient. In furtheralternatives, the color band may only cover certain angular segments ofthe reservoir, such as 180 degrees, 90 degrees, 45 degrees, 30 degrees,15 degrees or other suitable amount, with the selection being based uponthe width of color band required, orientation features of the reservoir,size of a color sensor or the like. For illustrative purposes only,colored markings 12A, 12B and 12C are shown in FIG. 1B to respectivelycover angular segments of 90 degrees, 180 degrees and 270 degrees of thereservoir 10. Although FIG. 1B shows multiple colored bands extendingaround the reservoir at respectively different angular segments, it iscontemplated that the multiple colored bands may also extend equallyaround the reservoir to cover equal angular segments. Moreover, theangular segments may be of any angle, and are therefore not limited tothe angles shown in FIG. 1B.

In particular embodiments, when the colored band covers a certainangular segment of the reservoir, a window 50 (shown in FIG. 2A) of thefluid delivery device may be sized large enough such that a color sensorof the device is able to detect at least a portion of the colored bandthrough the window 50 regardless of a distance between the color sensorand the reservoir inserted in the delivery device. Alternatively, whenthe colored band covers a certain angular segment of the reservoir, thereservoir may be configured such that it is inserted in the deliverydevice with a particular orientation so that a smaller portion of thecolored band is visible to the color sensor through the window 50, andtherefore makes it unnecessary for the colored band to extend all theway around the surface of the reservoir. Additionally, if the coloredband covers an angular segment of at least 180 degrees, and if theliquid in the reservoir is clear enough to accurately allow colors to betransmitted through, a label for attaching to the reservoir may beformed with color on both sides of the label. This allows the coloredmarking to be detected by the color sensor regardless of the reservoir'sorientation in the delivery device.

In alternative embodiments, the reservoir 10 may include a plurality ofcolored markings. As shown in FIG. 1C, different colored bands 12D, 12Eand 12F may encircle the reservoir 10. The colored bands may beseparated from each other or adjoin each other according to need,wherein the need may depend on a sensitivity and size of a color sensor,a size of the reservoir or the like. The different colored bands mayalso partially extend around the reservoir 10, as shown in FIG. 1B.

As shown in FIG. 1D, a colored band 12G comprising a plurality of colorsmay be located on the reservoir 10. Different colored regions mayalternate around the band 12G. In a particular embodiment, the differentcolored regions may be small in size such that a single color sensor ofa fluid delivery device is able to detect multiple color regions.Alternatively, the different colored regions may be spaced apart fromeach other such that a plurality of color sensors of the delivery devicemay be used to respectively detect the spaced-apart colored regions. Theplurality of color sensors may be co-located or separated in thedelivery device.

FIG. 2A illustrates a front plan, cut-away view of an exemplary fluiddelivery device according to a particular embodiment of the invention,in which a device 201, containing a lower section 202 for a power supply220 and electronic control circuitry (microprocessor) 222, accommodatesa driving device, such as a motor 203 (e.g., a solenoid, stepper or DCmotor), a first drive member, such as an externally threaded drive gearor screw 204, a second drive member, such as an internally threadedplunger gear or slide 205, and a removable reservoir 10. The reservoir10 may include a plunger or piston 207 with O-rings or integral raisedridges for forming a water and air tight seal. The reservoir 10 isinserted into a compartment in the device 201 and secured into thedevice 201 with a connector 231 which also serves as the interfacebetween the reservoir 10 and an infusion set adhered to the patient (notshown). In particular embodiments, the reservoir piston 207 is coupledto a plunger slide 205 by a releasable coupler. In the illustratedembodiment, the coupler includes a female portion 224 which receives amale portion 226 carried by the plunger slide 205. The female portion224 is positioned at the end face 228 of the piston 207 and includes athreaded cavity which engages the threads of a male screw extending fromthe end 230 of the plunger slide 205.

While particular embodiments of the present invention are directed todisposable, pre-filled reservoirs 10, alternative embodiments may useuser-filled, refillable, refurbished, or the like reservoirs 10. Thereservoir 10 can be pre-filled with insulin (or other drug or fluid) andinserted into the fluid delivery device. Alternatively, the reservoir 10may be filled by the patient using an adapter handle (not shown)attached to the piston 207 on the reservoir 10. After the reservoir 10is filled, the handle is removed (such as by unscrewing the handle) sothat the reservoir 10 can be placed into the fluid delivery device.

Referring to FIG. 2A, as the drive shaft 232 of the motor 203 rotates,the drive screw 204 drives the plunger slide 205 directly to obtain theaxial displacement against the reservoir piston 207 to deliver thepredetermined amount of medication or fluid. A gear box 250 couples thedrive screw 204 to the drive shaft 232 of the motor 203. When using a DCor stepper motor, the motor can be rapidly rewound when the reservoir isemptied or as programmed by the user. A sealing device, such as a seal209, is in contact with the plunger slide 205, thus allowing it to moveaxially while maintaining a water resistant barrier between the cavityholding the reservoir 10 and the motor 203. This prevents fluids andother contaminants from entering the drive system.

An anti-rotation key 210 is affixed to the plunger slide 205 and issized to fit within a groove (not shown) axially disposed in the device201. This arrangement serves to prevent motor and plunger slide rotationwhich might otherwise result from the torque generated by the motor 203in the event that the friction of the seal 209 is not sufficient aloneto prevent rotation.

The motor 203 is a motor, such as a DC or stepper motor, and is journalmounted in the device 201 by a mounting system 212. The mounting system212 can be useful in aiding motor startup.

The device 201 includes a light source 30 and a color sensor 32.Preferably, the light source 30 may be a single white light emittingdiode (LED) or a plurality of individual color LEDs. The color sensor 32may be a color sensing chip, photodiode or photo integrated circuit(photo IC). In one embodiment, a photo IC sensitive to red (λ=615 nm),green (λ=540 nm) and blue (λ=465 nm) regions of the color spectrum maybe used. In particular embodiments, detected signals may be seriallyoutput as 12-bit digital data. Thus, the photo IC may comprise three12-bit digital registers allowing simultaneous measurement of threecolors (red, green and blue). In alternative embodiments, smaller orlarger digital data bit sizes may be used, depending on the resolutionor number of colors that needs to be detected.

The colored marking 12 on the reservoir 10, and the light source 30 andcolor sensor 32 of the device 201, are purposefully placed such thatwhen the reservoir 10 is inserted into the device 201, the light source30 is able to shine light on the colored marking 12 while the sensor 32detects wavelengths reflected and/or refracted from the marking 12. Inparticular, the colored marking 12 surrounds the reservoir 10 so thatthe light source 30 is able to shine light on the colored marking 12,and the sensor 32 is able to detect the resulting wavelengths,regardless of the reservoir's orientation in the device. As shown inFIGS. 2B and 2C, the light source 30 and color sensor 32 are operativelycoupled to a printed circuit board (PCB) so as to be electricallycoupled with other electrical components of the device 201.

In particular embodiments, the inserted reservoir 10 is separatelyencased within the device 201 to form a fluid-tight seal around thereservoir 10 to protect the reservoir fluid from contaminants, and toprotect device components, such as the light source 30 and sensor 32,from contacting any fluid escaping from the reservoir 10. Accordingly, awindow 50 may be formed on a wall separating the reservoir 10 from thelight source 30 and sensor 32, as shown in FIG. 2A. This allows thelight source 30 to shine light on the colored marking 12 of thereservoir 10 and the sensor 32 to detect the reflected and/or refractedwavelengths from the reservoir 10 while being protected from any harmfulfluid. Preferably, the window 50 is made of a polycarbonate material.Moreover, the sensor 32 is capable of detecting the wavelengths throughthe window 50 regardless of the window being distorted or dirty.

In another embodiment, the window 50 is not used. Rather, the wallseparating the reservoir 10 from the light source 30 and sensor 32 is atranslucent material of the device 201, which allows light to passthrough. In this embodiment, the source 30 is able to shine light ontothe marking 12, and the sensor 32 is capable of detecting the reflectedwavelengths through the translucent wall to detect the color of themarking 12. In alternative embodiments, other case colored materials maybe used, as long as they do not interfere with the ability to detect anddetermine the color.

The device 201 further includes the microprocessor 222 operativelycoupled to the sensor 32 via the PCB shown in FIGS. 2B and 2C, forexample. In particular, the microprocessor 222 is programmed withcontrol algorithms to receive output data from the sensor 32 todetermine a specific color of the marking 12. For instance, the controlalgorithms used for detecting the color of the marking 12 when utilizingthe above-stated translucent material may be different from the controlalgorithms used when a clear window is utilized. Additionally, inparticular embodiments, the fluid delivery device 201 has an opaquehousing, although in alternative embodiments, the housing may betranslucent. The control algorithms used for detecting the color of themarking 12 when the housing is opaque may be different from the controlalgorithms used when the housing is translucent.

In one embodiment, different colored markings on the reservoir 10correspond to different medications or medication concentrations,respectively. For example, the color green may correspond to U100insulin, the color red may correspond to U200 insulin, etc. Accordingly,if the microprocessor 222 determines that the colored marking 12 isgreen, it can then ascertain the medication contained in the reservoir(i.e. U100 insulin). Upon confirming that U100 insulin is theappropriate medication to deliver, the microprocessor can then operatethe device 201 to properly deliver the medication to the patient.

In an alternative embodiment, in lieu of or in addition to a coloredmarking 12 placed on the reservoir 10, color may be added to themedication itself for purposes of direct identification of themedication by the color sensor 32. Accordingly, embodiments of thepresent invention described herein with respect to the colored marking12 are also applicable to colored medication within the reservoir 10.

It is contemplated that any number of colors may be used in accordancewith embodiments of the present invention to arbitrarily correspond to arespective medication. Moreover, the embodiments of the presentinvention are not limited to colors in the visible spectrum. It iscontemplated that the marking 12 may also be of an infrared color, thewavelengths of which are detectable by the sensor 32.

In other embodiments, different colored markings on the reservoir 10 mayindicate other information such as medication type (e.g. type ofinsulin), expiration date, amount of medication contained in thereservoir, maker of the medication, medication dosage, proper insertionof the reservoir, reservoir size, reservoir material (e.g. Topas®,glass, etc.) or the like. Thus, upon the microprocessor 222 ascertainingthis information, the microprocessor 222 may operate the device 201according to the information.

In particular embodiments, the relationship between an arbitrary colorand corresponding information (e.g., medication type, reservoir size,etc.) is previously known by the device 201 and may be stored in amemory (not shown) of the device 201. The device memory may be preloadedwith such information during manufacture of the device. Alternatively,the user may download such information onto the device memory from anexternal source.

In one embodiment, information deduced from the colored marking may becommunicated to a user/patient via a display of the device 201. Forexample, when the colored marking of the reservoir 10 is detected by thesensor 32, the control algorithms of the device 201 may first deduce thetype of medication contained in the reservoir, and convey thisinformation to the user. The user is then able to visually confirmwhether the currently connected reservoir contains the correctmedication to receive. The information may also be communicated to otherdevices such as a controller or bedside monitor.

In another embodiment, the information may also be used by the device201 to improve performance. For example, instead of the user visuallyconfirming the correct medication on the device display, the controlalgorithms may automatically deduce that the currently connectedreservoir contains the incorrect medication, and subsequently notify theuser/patient of the error via an alarm, for example, and/orautomatically stop delivery of the medication. In another example, inthe event that the correct medication is present in the reservoir, thecontrol algorithms may automatically operate the device to deliver themedication according to pre-determined delivery parameters related tothe determined color and/or the medication. Accordingly, depending onimplementation, when the specific color of the marking 12 is determined,different control algorithms of the device 201 may be driven accordingto the determined color to perform different device functions. Forexample, the algorithms for detecting an occlusion in the device 201 maybe varied depending on the medication type indicated by the coloredmarking 12. If the colored marking 12 indicates that the reservoir 10contains a lower insulin concentration (e.g., U50, U100), the occlusionsensitivity may be lower than if the colored marking 12 indicates thatthe reservoir 10 contains a higher insulin concentration (e.g., U200,U400).

In one embodiment, when the sensor 32 does not detect a color within acertain amount of time, the control algorithms recognize a global lackof any reservoir in the device 201. Accordingly, the device 201initiates a safety check to inform the user/patient of the missingreservoir and may prompt the user/patient to insert a reservoir, orotherwise investigate the reason for why no reservoir is detected.Alternatively, the control algorithms can determine the lack of areservoir in the device 201 when the sensor 32 detects a color of thedevice compartment for receiving the reservoir.

FIG. 3 illustrates a method of operation of a fluid delivery system inaccordance with embodiments of the present invention. Referring to FIG.3, a user inserts a reservoir 10 (e.g., vial containing medication to bedelivered to the user) having a colored marking 12 into a device 201(3010). Once the reservoir 10 is inserted, a light source 30 (e.g. LED)and a color sensor 32 (e.g. photodiode) are powered (3020). As the lightsource 30 shines light onto the colored marking 12, wavelengthsreflected and/or refracted from the colored marking 12 are detected bythe color sensor 32 (3030). The color sensor 32 then sends a signalrepresenting detected wavelength values to a signal processor (3050),wherefrom a microprocessor 222 attempts to determine a color of thecolored marking 12 on the inserted reservoir 10 (3060).

If no color is detected, or if an identified color is new to theprocessor (3070), the processor may determine that no reservoir isinserted, the reservoir is incorrectly inserted or the reservoircontains an unknown medication type, for example (3080). Accordingly,the device 201 may then prompt the user to perform a safety orcorrective action (3090). For example, the user may be instructed tocheck for the reservoir's presence in the device 201, or check that thereservoir is properly positioned in the device.

If an identified color of the reservoir is previously known to theprocessor (3071), the processor determines that the color is associatedwith information related to the reservoir or fluid in the reservoir(3100). The information may include a medication type, a medicationexpiration date, an amount of medication contained in the reservoir, amaker of the medication, a medication dosage, a reservoir size, areservoir material, or a medication concentration. The information maybe provided to the user via a device display or device controller(3110), wherein the user may confirm the medication information (3120).

Once the user confirms the medication to be delivered, the device 201may make appropriate delivery adjustments according to thecharacteristics of the medication (3130) and deliver the medicationaccordingly (3140). During delivery, the device 201 may check whetherthe detected color is the same as the color detected during programmeddelivery. If so, then the medication delivery continues (3150). However,if the detected color is not the same, then an alarm may be triggered tonotify the user of the discrepancy (3160).

In accordance with embodiments of the present invention, the controlalgorithms may gather reference points to account for ambient light,variations in tolerances, and component drifts in the device 201, andthus, promote the reliability and robustness of the device 201. Forexample, in particular embodiments, the fluid delivery device 201 has anopaque housing, although in alternative embodiments, the housing may betranslucent. If the housing is translucent, the control algorithms mustaccount for the ambient light in order to correctly detect the color ofthe marking 12. Thus, the control algorithms may gather reference pointsto determine the amount of ambient light and accordingly adjust todetect the color of the marking 12.

In other embodiments of the present invention, the colored marking 12may be placed on structures other than the reservoir 10. For example,the colored marking may be placed on the connector 231 connecting thereservoir 10 to an infusion set. Accordingly, the device 201 mayascertain information related to the connector 231 or infusion set(e.g., tubing length, cannula length, type of infusion set, manufacturerof the infusion set, or the like) when the colored marking is detectedby the color sensor 32, or another sensor positioned on the device 201to detect wavelengths reflected and/or refracted from the coloredmarking on the connector 231. For instance, if color identified thelength of the tubing, cannula length, or the like, the amount of fluidneeded for the device to prime the infusion set and tubing could beautomatically adjusted. The colored marking may also be placed on otherportions of medical devices or accessories attached to the patient, suchas tubings, cannulas, or the like for a color sensor of the device 201to be able to ascertain information related to the respective medicaldevice or accessory. In particular embodiments, a correspondingrelationship between a detected color on a specific medical device oraccessory and information related to the specific medical device oraccessory is previously known by the device 201 and may be stored in amemory of the device 201.

In other embodiments of the present invention, the colored marking 12 onthe reservoir 10 may be manipulated to indicate various types ofinformation to the device 201. For example, in one embodiment, themarking 12 may form a narrow colored band on the reservoir 10.Accordingly, the narrow band may be used to determine whether thereservoir 10 is positioned in the device 201 correctly. Specifically,because the narrow band poses as a smaller target for the light source30 to shine light on, if the reservoir 10 is placed in a less-than-idealposition in the device 201, the light may only hit a portion of thecolored band, and therefore a weaker signal is produced for the sensor32 to detect. The weaker signal is indicative of the reservoir beingpositioned incorrectly in the device.

In another embodiment, the colored marking 12 on the reservoir 10 may bemade to purposefully change color to indicate changes in conditionsrelated to the reservoir 10 or reservoir fluid. For example, acontrolled fade of the colored marking may be implemented to indicatethe age of the reservoir fluid, or whether the reservoir fluid hasexpired. Furthermore, a change in color of the marking may be used toindicate the age of the reservoir itself. This may be helpful whenutilizing reusable/refillable reservoirs. Thus, a user is informed bythe color change if a reservoir is too old and unsafe to use.Alternatively, the change in color of the marking may also indicatewhether the reservoir or the reservoir fluid has been damaged due totemperature, water or air exposure.

In other embodiments, a plurality of colored markings may be placed onthe reservoir 10 to indicate large amounts, or different types, ofinformation to the device 201. Accordingly, the device 201 may have oneor more color sensors to detect wavelengths of the plurality of coloredmarkings, and allow the device 201 to ascertain informationcorresponding to the plurality of colors detected. In one embodiment,use of a second color sensor allows for more accurate color readings.For example, the second color sensor may function to confirm wavelengthreadings detected by a first color sensor. Accordingly, when determiningthe color of a colored marking on the reservoir, control algorithms maysubtract out colors that are not part of the reservoir by using baselineinformation known to the device along with the readings from the twocolor sensors. In particular, use of the second sensor adds minimal sizeto the device.

The reservoir according to embodiments of the present invention used inconjunction with the light source 30 and light sensor 32 of the device201 is an improvement over previous systems which utilize alternativemethods for providing information about the reservoir to the deliverydevice. In an example of a previous system, a reservoir having a barcode for use with a delivery device having a bar code reader isemployed. The bar code design requires large room in the device becausethe bar code reader is required to be a certain distance away from thebar code for its reading mechanism to correctly focus on the bar code.Moreover, the bar code design requires the reservoir to be preciselypositioned in the device so that the bar code reader can properly alignitself with the bar code. Hence, any slight movement of the reservoiraway from its ideal position in the device will hinder the bar codereader from accurately reading the bar code and produce unreliablereadings. Additionally, the bar code design is susceptible to misreadingO-rings of the reservoir as bar codes. Also, the bar code reader hasdifficulty reading the bar code when a window between the reservoir andthe bar code reader is unclear or distorted, or when the bar code itselfis unclear or distorted (e.g., debris on the bar code, scratched/damagedbar code label). Furthermore, in the bar code design, more bars arerequired on the reservoir to indicate more information. However, theneed for more bars on the reservoir requires a larger window between thereservoir and the bar code reader to allow the bar code reader to focuson the wider bar code. This is disadvantageous because the larger windowincreases the size of the device.

Use of color in accordance with the embodiments of the present inventionis a more reliable and less cumbersome method of providing informationregarding the reservoir, or contents of the reservoir, to the deliverydevice. It is less demanding for the color sensor 32 to be able todetect wavelengths reflected and/or refracted from the marking 12 on thereservoir 10 than it is for a bar code reader to read a bar code. Thecolor sensor 32 does not require as much space between itself and thereservoir 10. Thus, less room is required in the delivery device 201 ofthe present invention, and therefore smaller devices may bemanufactured. Moreover, in the present embodiments, the reservoir 10does not require precise positioning in the device 201 because the colorsensor 32 is able to detect wavelengths reflected and/or refracted fromthe marking 12 surrounding the reservoir 10 even when reservoirpositioning is less than ideal. Additionally, the color sensor 32 isable to detect wavelengths through an unclear or distorted window. Also,because only the color of the marking 12 is being informed to the colorsensor 32, a small window size is adequate, and therefore reduces thesize of the device.

In accordance with another embodiment, the present invention may beimplemented in a characteristic sensor system. Such system may include acharacteristic monitor operationally coupled to a sensor set insertedinto a patient's body to determine levels of a characteristic in thepatient's body, such as blood glucose levels. FIGS. 4A and 4B illustratea characteristic sensor system 400 comprising a subcutaneous sensorinsertion set 410 and a telemetered characteristic monitor transmitter420. Description of a telemetered characteristic sensor system may befound in commonly owned co-pending application Ser. No. 11/322,568entitled “Telemetered Characteristic Monitor System and Method of Usingthe Same” filed on Dec. 30, 2005, which is incorporated by reference inits entirety. In a particular embodiment, the transmitter 420 and thesensor insertion set 410 are configured to directly connect with, anddetach from, each other. FIG. 4A is a perspective view illustrating thetransmitter 420 connected with the sensor set 410. FIG. 4B is a top viewillustrating the transmitter 420 detached from the sensor set 410. Thetransmitter 420 communicates with a characteristic monitor 430 totransmit information detected by the sensor set 410. The monitor 430utilizes the transmitted information to determine the characteristicreading of the patient. The monitor 430 may include a display 440 todisplay the results of the characteristic reading to the user.

In one embodiment, the colored marking 12 may be located on the sensorset 410 and a light source and color sensor may be formed on, or within,a portion of the transmitter 420 that contacts a portion of the sensorset 410 having the colored marking 12 when the transmitter 420 andsensor set 410 are coupled to each other. For example, as shown in FIG.5A, the colored marking 12 may be formed on a tubular portion 450 of thesensor set 410. Accordingly, a light source 30 and color sensor 32 maybe formed within the transmitter 420. As shown in FIG. 6B, a window 50may be formed on an inner wall of an interface 460 of the transmitter420. Thus, when the sensor set 410 is operationally coupled to thetransmitter 420 by inserting the tubular portion 450 into the interface460, the light source 30 housed within the transmitter 420 can shinelight on the colored marking 12 through the window 50. The sensor 32housed within the transmitter 420 can also detect wavelengths reflectedand/or refracted from the tubular portion 450 through the window 50. Assuch, when the light source shines light on the colored marking 12 andwavelengths reflected and/or refracted from the marking 12 are sensed bythe color sensor, information related to the sensor set 410 or themonitored characteristic may be indicated to the monitor 430 accordingto a color of the marking 12. The color may be determined by a processoroperatively coupled to the color sensor or the monitor 430. Theprocessor may also ascertain the information from a transmitter memoryor monitor memory according to the determined color. The information mayinclude usage life of the sensor (e.g., 3 days, 6 days), an analytebeing sensed (e.g, glucose, lactate, bacterial, viral, ph, oxygen, orthe like), calibration data, alarm thresholds, lot number, or the like.The location, form and number of the colored markings 12 as shown inFIG. 5A is for illustrative purposes only. In accordance with thepresent invention, any number of colored markings may be placed, in anyform, on any location of the tubular portion 450 or the sensor set 410in general. Furthermore, the location, size and shape of the window 50as shown in FIG. 6B is for illustrative purposes only. The window 50 maybe formed at any inner wall portion of the interface 460, or on anysurface of the transmitter 420, and may have any size and shape.

In another embodiment, as shown in FIG. 5B, the colored marking 12 maybe formed on a rear wall surface of the sensor set 410 wherefrom thetubular portion 450 extends, or on a rear wall surface of a cantileveredlatch arm 415. As shown in FIG. 6A, a window 50 may be formed on a frontwall surface of the transmitter 420. Thus, when the sensor set 410 iscoupled to the transmitter 420 by snap-fitting a latch tip of the latcharm 415 into a corresponding latch recess of the transmitter 420, thecolored marking 12 of the sensor set 410 may be visible to the lightsource 30 and color sensor 32 of the transmitter 420 through the window50. As such, as described above, when the light source shines light onthe colored marking 12 and wavelengths reflected and/or refracted fromthe marking 12 are sensed by the color sensor, information related tothe sensor set 410 or the monitored characteristic may be indicated tothe monitor 430 according to a color of the marking 12. The location,form and number of the colored markings 12 as shown in FIG. 5B is forillustrative purposes only. In accordance with the present invention,any number of colored markings may be placed, in any form, on anysurface of the sensor set 410. Furthermore, the location, size and shapeof the window 50 as shown in FIG. 6A is for illustrative purposes only.The window 50 may be formed at any wall portion, or on any surface ofthe transmitter 420, and may have any size and shape.

The foregoing embodiments and advantages are merely exemplary and arenot to be construed as limiting the present invention. The presentteaching can be readily applied to other types of apparatuses. Thedescription of the present invention is intended to be illustrative, andnot to limit the scope of the claims. Many alternatives, modifications,and variations will be apparent to those skilled in the art. In theclaims, any means-plus-function clauses are intended to cover thestructure described herein as performing the recited function and notonly structural equivalents but also equivalent structures.

1. A characteristic monitor system for monitoring a characteristic of auser, the system comprising: a remote device; a sensor set supporting asensor for producing a signal indicative of the characteristic of theuser; at least one colored marking located on a surface of the sensorset for providing information related to the sensor set or thecharacteristic of the user; and a transmitter coupled to the sensor setfor processing signals from the sensor set and transmitting theprocessed signals to the remote device, wherein the remote deviceutilizes the received processed signals to determine the characteristicof the user, the transmitter comprising: a light source for shininglight on the at least one colored marking of the sensor set, a colorsensor for detecting wavelengths reflected and/or refracted from the atleast one colored marking due to the light shined on the at least onecolored marking, and a processor operatively coupled to the color sensorfor determining a color of the at least one colored marking from thedetected wavelengths and ascertaining information related to the sensorset or the monitored characteristic corresponding to the determinedcolor.
 2. The system of claim 1, wherein the information comprises atleast one of: usage life of the sensor; an analyte being sensed;calibration data; alarm thresholds; and lot number.
 3. The system ofclaim 1, wherein the transmitter further comprises a window throughwhich the light source shines light on the at least one colored markingof the sensor set and the color sensor detects wavelengths reflectedand/or refracted from the at least one colored marking.
 4. The system ofclaim 3, wherein the window is formed on a front wall surface of thetransmitter.
 5. The system of claim 4, wherein the at least one coloredmarking is formed on a rear wall surface of the sensor set.
 6. Thesystem of claim 3, wherein the window is formed on an inner wall surfaceof an interface of the transmitter.
 7. The system of claim 6, whereinthe at least one colored marking is formed on a portion of the sensorset that inserts into the interface when the sensor set is coupled tothe transmitter.
 8. A characteristic monitor system for monitoring acharacteristic of a user, the system comprising: a sensor set supportinga sensor for producing a signal indicative of the characteristic of theuser; at least one colored marking located on a surface of the sensorset for providing information related to the sensor set or thecharacteristic of the user; and a transmitter coupled to the sensor setfor processing signals from the sensor set to determine thecharacteristic of the user, the transmitter comprising: a light sourcefor shining light on the at least one colored marking of the sensor set,a color sensor for detecting wavelengths reflected and/or refracted fromthe at least one colored marking due to the light shined on the at leastone colored marking, a window through which the light source shineslight on the at least one colored marking of the sensor set and thecolor sensor detects wavelengths reflected and/or refracted from the atleast one colored marking, and a processor operatively coupled to thecolor sensor for determining a color of the at least one colored markingfrom the detected wavelengths and ascertaining information related tothe sensor set or the monitored characteristic corresponding to thedetermined color.
 9. The system of claim 8, wherein the window is formedon a front wall surface of the transmitter.
 10. The system of claim 9,wherein the at least one colored marking is formed on a rear wallsurface of the sensor set.
 11. The system of claim 8, wherein the windowis formed on an inner wall surface of an interface of the transmitter.12. The system of claim 11, wherein the at least one colored marking isformed on a portion of the sensor set that inserts into the interfacewhen the sensor set is coupled to the transmitter.
 13. The system ofclaim 8, wherein the information comprises at least one of: usage lifeof the sensor; an analyte being sensed; calibration data; alarmthresholds; and lot number.
 14. A characteristic monitor system formonitoring a characteristic of a user, the system comprising: a sensorset supporting a sensor for producing a signal indicative of thecharacteristic of the user; at least one colored marking located on asurface of the sensor set for providing information related to thesensor set or the characteristic of the user; and a transmitter coupledto the sensor set for processing signals from the sensor set todetermine the characteristic of the user, wherein the at least onecolored marking is formed on a portion of the sensor set that insertsinto the transmitter when the sensor set is coupled to the transmitter,the transmitter comprising: a light source for shining light on the atleast one colored marking of the sensor set, a color sensor fordetecting wavelengths reflected and/or refracted from the at least onecolored marking due to the light shined on the at least one coloredmarking, an interface for receiving the portion of the sensor set thatinserts into the transmitter, a window formed on an inner wall surfaceof the interface through which the light source shines light on the atleast one colored marking of the sensor set and the color sensor detectswavelengths reflected and/or refracted from the at least one coloredmarking, and a processor operatively coupled to the color sensor fordetermining a color of the at least one colored marking from thedetected wavelengths and ascertaining information related to the sensorset or the monitored characteristic corresponding to the determinedcolor.
 15. The system of claim 14, wherein the information comprises atleast one of: usage life of the sensor; an analyte being sensed;calibration data; alarm thresholds; and lot number.
 16. A characteristicmonitor system for monitoring a characteristic of a user, the systemcomprising: a sensor set supporting a sensor for producing a signalindicative of the characteristic of the user; at least one coloredmarking located on a rear wall surface of the sensor set for providinginformation related to the sensor set or the characteristic of the user;and a transmitter coupled to the sensor set for processing signals fromthe sensor set to determine the characteristic of the user, thetransmitter comprising: a light source for shining light on the at leastone colored marking of the sensor set, a color sensor for detectingwavelengths reflected and/or refracted from the at least one coloredmarking due to the light shined on the at least one colored marking, awindow formed on a front wall surface of the interface through which thelight source shines light on the at least one colored marking of thesensor set and the color sensor detects wavelengths reflected and/orrefracted from the at least one colored marking, and a processoroperatively coupled to the color sensor for determining a color of theat least one colored marking from the detected wavelengths andascertaining information related to the sensor set or the monitoredcharacteristic corresponding to the determined color.
 17. The system ofclaim 16, wherein the information comprises at least one of: usage lifeof the sensor; an analyte being sensed; calibration data; alarmthresholds; and lot number.